Early Phase Drug Evaluation in ManJohn O'Grady, Otto I Linet CRC Press, 2020 M02 3 - 737 pages Early Phase Drug Evaluation in Man is a comprehensive, practical guide that covers pre-clinical information relevant to early human studies, including pharmaceutical, metabolic, toxicological, and regulatory aspects, as well as the general considerations relevant to all early human studies. Each major therapeutic area is considered by class of activity of drug. The chapters describe what measurements of drug activity are available in healthy human subjects and in patients, how to make the measurements, their value and their limitations. The contributors have been drawn internationally from the pharmaceutical industry and academia. Early Phase Drug Evaluation in Man will provide an important reference guide for industry and academic professionals involved in the development of new drugs. |
From inside the book
Results 1-5 of 85
Page x
... major classes of activity . Early clinical development cannot , however , be divorced from the preclinical studies which provide essential and often predictive information in relation to clinical safety and efficacy . We have dealt with ...
... major classes of activity . Early clinical development cannot , however , be divorced from the preclinical studies which provide essential and often predictive information in relation to clinical safety and efficacy . We have dealt with ...
Page 6
... major markets around the globe would indicate that tablets and capsules are by far the most widely used dosage form , primarily because of advances in the technology of manufacture , flexibility in dosing , stability , elegance and ease ...
... major markets around the globe would indicate that tablets and capsules are by far the most widely used dosage form , primarily because of advances in the technology of manufacture , flexibility in dosing , stability , elegance and ease ...
Page 16
... major physiological systems by use of a variety of experimental models . Indeed , the Japanese authorities have suggested that another scientific reason for conducting the secondary pharmacological tests could be to explore whether the ...
... major physiological systems by use of a variety of experimental models . Indeed , the Japanese authorities have suggested that another scientific reason for conducting the secondary pharmacological tests could be to explore whether the ...
Page 21
... major purpose unless appropriate for the anticipated clinical utility . These data on the NCE are often generated in general screening schemes , and once they are available it is felt that they should be reported . If the compound ...
... major purpose unless appropriate for the anticipated clinical utility . These data on the NCE are often generated in general screening schemes , and once they are available it is felt that they should be reported . If the compound ...
Page 29
... major effect on the disposition of drugs inasmuch as drugs must gain entry to the body and / or body tissues by penetration of a succession of lipoidal membranes . Ideally , the physicochemical properties of drugs should be evaluated ...
... major effect on the disposition of drugs inasmuch as drugs must gain entry to the body and / or body tissues by penetration of a succession of lipoidal membranes . Ideally , the physicochemical properties of drugs should be evaluated ...
Contents
Organisation and Decision Making | 97 |
Ethical and Legal Considerations | 137 |
Measuring Drug Activity in Man | 193 |
Assessment of Drug Effects on the Cardiovascular System ... | 251 |
Assessment of Drug Effects on the Respiratory System ... | 349 |
Assessment of Drug Effects on the Central Nervous System ... | 377 |
Assessment of Drug Effects on the Gastrointestinal System ... | 455 |
Assessment of Drug Effects on the Kidney | 493 |
Assessment of the Effects of Drugs Used in Obstetrics and Gynaecology ... | 519 |
Assessment of Drug Activity in the Skin | 551 |
Assessment of Drugs Used for the Treatment of Metabolic Disorders ... | 599 |
Assessment of the Effects of Chemotherapeutic Agents ... | 625 |
Assessment of Drugs Affecting the Inflammatory Process and Pain ... | 655 |
Index | 703 |
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absorption acid action activity acute administration adverse agents analgesic animal antidepressant anxiety anxiolytic assay assessment asthma benzodiazepines bioavailability biological blood pressure cardiac output cells changes chronic Clin clinical research clinical trials compound concentration consent coronary corticosteroids determine disease diuretics dosage dose drug development duration eczema effects of drugs efficacy enantiomers enzyme ethics committee evaluation excretion exercise experimental factors function gastric gastrointestinal gastrointestinal tract glucose guidelines healthy volunteers heart human important increase induced inhibition insulin intravenous investigator laboratory levels measurement metabolism metabolites method minoxidil monitoring myocardial normal NSAIDs oral pain parameters patients performed Pharm pharmaceutical pharmacodynamic pharmacokinetic pharmacological placebo plasma platelet potential preclinical predictive produce prostaglandin protocol receptor regulatory renal response rheumatoid arthritis risk safety scales Shuster side-effects skin specific studies subjects symptoms techniques therapeutic therapy tion tolerance toxicology treatment urine uterine visual analogue scales vitro vivo